A Study to Evaluate the Pharmacokinetics and Safety of Diluted vs. Undiluted Intravenous DA-5217 in Healthy Adult Subjects

Phase 1

Completed

• Conditions: Healthy Adults
• Interventions: Drug: Diluted Intravenous DA-5217; Drug: Undiluted Intravenous DA-5217

• Registration Number: NCT07027982
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

This study will evaluate the pharmacokinetics and safety of Diluted and Undiluted Intravenous DA-5217 in healthy adult subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-11
• Study First Posted: 2025-06-19
• Study Start: 2025-07-16
• Status Verified: 2025-08
• Primary Completion: 2025-08-14
• Study Completion: 2025-08-14
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Healthy adult male or female, 19 years to 45 years
• Weighing 50 kg or more, with a body mass index (BMI) of 18.5 kg/m2 to 29.9kg/m2
• The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate and complied with the precautions.

Exclusion Criteria

• The subjects with existing or previous conditions that may influence the pharmacokinetics of drugs
• The subjects hypersensitive to any of the Investigational Product components or other drug components
• The subjects with clinically significant active chronic conditions
• The subjects with a positive urine drug test result or a history of drug abuse or dependence.
• The subjects who are pregnant or lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	Diluted Intravenous DA-5217	-
Sequence 1	Undiluted Intravenous DA-5217	-
Sequence 2	Diluted Intravenous DA-5217	-
Sequence 2	Undiluted Intravenous DA-5217	-

Primary Outcome Measures

Name	Time	Method
AUClast	0~24hours	Area under the plasma concentration-time curve from time zero to time the last quantifiable time

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of